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HomeELITECHGROUP INC. › ChloroChek® Reagent Set, 37x10mL BS + 1x30mL GS

ChloroChek® Reagent Set, 37x10mL BS + 1x30mL GS

ELITECHGROUP INC. · Model SS-248 · UDI-DI 03661540304095

JFS
1
510(k) clearances
0
Adverse events
2
Recalls
2
Facilities

Description

The ChloroChek Chloridometer Reagent Set is intended for the quantitative in vitro diagnostic determination of chloride in human sweat using the principle of coulometric titration when used with the ChlorChek Chloridometer.

Recalls

DateFirmReason
2016-09-02Siemens Healthcare Diagnostics IncError in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge
2016-09-02Siemens Healthcare Diagnostics IncError in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.